FDA 510(k) Application Details - K981709

Device Classification Name	Plasma, Coagulation Factor Deficient   More FDA Info for this Device
510(K) Number	K981709
Device Name	Plasma, Coagulation Factor Deficient
Applicant	DADE BEHRING, INC. 3403 YERBA BUENA RD. SAN JOSE, CA 95161-9013 US Other 510(k) Applications for this Company
Contact	MARIO A LOWE Other 510(k) Applications for this Contact
Regulation Number	864.7290   More FDA Info for this Regulation Number
Classification Product Code	GJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/1998
Decision Date	10/13/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review